Carbon Ion Radiotherapy for Atypical Meningiomas (MARCIE)
Recruitment status was Not yet recruiting
Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.
Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.
Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.
Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Patients With Atypical Meningiomas Simpson Grade 4 and 5 With a Carbon Ion Boost in Combination With Postoperative Photon Radiotherapy: A Phase II Trial|
- Progression-free survival [ Time Frame: Progression-free survival at 3 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Overall Survival at 3 years ]
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Carbon Ion Radiotherapy Boost
Carbon Ion Boost to the Macroscopic Tumor visible on contrast-enhanced MR-Imaging
Radiation: Carbon Ion Radiotherapy
Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166321
|Contact: Jürgen Debus, MD PhD||+49-6221-56- ext email@example.com|
|Contact: Stephanie E Combs, MD||+49-6221-56- ext firstname.lastname@example.org|
|University Hospital of Heidelberg, Radiation Oncology|
|Heidelberg, Germany, 69120|